11+ ISO 13485 Jobs in Pune | ISO 13485 Job openings in Pune

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview

Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.

Key Skills & Knowledge :

• Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
• Experience with FDA and EU MDR regulatory requirements

Responsibilities :

• Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
• Analyze and implement design changes, assess impact, and update documentation accordingly
• Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
• Assess compliance with applicable standards and regulations
• Define CTS/CTQ parameters and actively participate in design reviews
• Follow QMS guidelines and manage changes through PLM.

The key aspects of this role:

• Candidate with exceptional programming skills, problem-solving abilities and strong work ethic.

• The candidate has to work on custom programming and web application development for Drupal.

• Testing, maintenance and troubleshooting of existing company sites and resolving issues if any.

• Contributing ideas and efforts towards internal projects and working as part of a team to find solutions on various problems.

• Communicate technical ideas to business users and other teams (design, QA).

• Collaborate with team members and to work independently when needed.

• Eager to embrace current and emerging web technologies.

To be the right fit, you'll need:

• Experience of total 4+ years working on PHP and Drupal 7,8 Development (at least 2+ years in Drupal 8)

• Strong knowledge of MySQL, jQuery, HTML5, CSS

• Experience with Drupal architecture, best practices and coding standards

• Knowledge on Views, Services etc.

• Experience in custom module and theme creation

• Familiar with sub version control systems such as Git or SVN

• Basic knowledge of environment setup for Linux distribution

• Assist in project scoping and interact with users to gather requirements
• Must have skills: Java,Spring,SQL,Web App development
• Produce well-planned, well-structured, high-quality codes that have been independently unit tested
• Design, develop, implement and maintain multi-tier web based applications using Java, J2EE, Struts, MVC, Weblogic, XML, Spring, Hibernate, and Oracle, to support business requirements (angular will be advantage)
• Participate and contribute actively in the complete software development lifecycle, including performance analysis, design, development, and testing
• Ensure well designed, testable, efficient codes by performing unit testing with test cases and through rigorous integration testing of the entire application
• Ensure designs are in compliance with specifications
• Support users by developing design documentation and assistance tools
• Interact regularly with internal and external teams to address technical issues and provide appropriate solutions through debugging, research, and investigation
• Develop configuration tools for internal teams to further automate programming tasks that are repetitive
• Engage in and lead application performance tuning

• Graduate/Post Graduate degree in Computer Science, Engineering or a related subject
• Proven working experience in Java development, application of standard software development principles and designing and developing applications using Java EE platforms
• Experience in developing web applications using at least one popular web frameworks using MVC
• Object oriented analysis and design using common design patterns
• Able to respond to technical queries / requests from team members and customers
• Profound insight of Java and JEE internals (Classloading, Memory Management, Transaction management etc.)
• Excellent knowledge of Relational Databases, SQL and ORM technologies (Oracle, Hibernate)
• Experience in the Spring Framework
• Experience with test-driven development

Urgent requirement for IT Recruiter for a US-based MNC

Apply only if you have experience in End to end It Recruitment.

Apply only if okay for CIEL HR payroll.

Please note the notice period. we are looking for an immediate to 15 days joiner only.

Experience: 3+ years

Location: Baner, Pune(looking for people in Pune only)

Notice Period: Immediate to 15 days

Working: currently WFH

Skills: End to End recruitment, Stakeholder management, Bulk hiring

Find JD

         5+ Years of experience SAP ABAP Consultant

• Experience of supporting medium/large scale Support / implementation / SAP ECC on HANA .
• Worked with SAP MM, SD, FICO and HCM.Having experience in S4 HANA implementation.
• Absolute understanding of mapping technical designs to Functional Documents (FS) & creating/reviewing corresponding Technical Specs (TS).
• Detailed & exhaustive understanding of coding practices & naming conventions in ABAP.
• Deliver of New Business Request/ Change Request with good quality, the defined timeline and the defined budget Data Dictionary Concepts (Mandatory)Report development classical / Interactive / ALV ,SAP Script / Smart forms /Adobe Forms Module Pool ,SAP BAPI/RFC Performance optimizations
• Proficient in finding correct User Exit / SAP Enhancements Points and SAP BADI.IDOC Configuration, extensions, custom IDOC (Mandatory as working knowledge , if not complete hands-on)
• Interface developmentExcellent client facing consulting skills , analytical skills and debugging
• Should be well versed with SAP standards and best practices.Experience with OSS Note application & validation.Strong client facing
• Demonstrate the ability to plan, run, and manage and sustain the operation support service delivery according to agreed SLA with quality and customer satisfaction by following ITSM
• Working knowledge of industry project processes and frameworks, such as CMMI/ITIL.

Training –

Training undergraduate science students to develop Games using software such as Unity, Unreal Engine, C# & C++ programming language. Should be able to clearly explain to students - OOP’s concept, programming logics & algorithms. Also, should be fully conversant with 12th level Mathematics and Physics concepts (such as Vector, Coordinate System, Matrices, Quaternion etc.) used in game programming

Specific Skill Set :

-  Strong working knowledge and experience of C#, C++ & Game engine (Unity3D, unreal engine, Cocos2d etc…) its application in game development is must & required (training, working experience)

-    Very strong knowledge of OOP’s concept (Such as Encapsulation, Inheritance, polymorphism etc.), programming logics & Algorithms is mandatory

-     Thorough with Mathematics, Physics & its Concepts (such as Vector, Coordinate System, Matrices, Quaternion etc.)

-      Good communicator (both oral and written) in English

-      Self-motivated, initiator and results-oriented

-      Should demonstrate positive attitude, high motivation and interpersonal skills

Minimum/Maximum/ Work Experience Required: – 3-5 years

Any other skill set:

Enjoys working with people of all ages, from youth to parents and College staff

Efficiently organized, with the ability to maintain detailed records

Ability to execute events in a well-coordinated and planned manner Encouraging Compassionate

Time management and follow-up skills

* Software professional who are passionate to teach and share knowledge, will be preferred.

• You will be responsible for design, development and testing of Products
• Contributing in all phases of the development lifecycle

• Writing well designed, testable, efficient code
• Ensure designs are in compliance with specifications

• Prepare and produce releases of software components

• Support continuous improvement by investigating alternatives and technologies and presenting these for architectural review

• Some of the technologies you will be working on: Core Java, Solr, Hadoop, Spark, Elastic search, Clustering, Text Mining, NLP, Mahout and Lucene etc.